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‘A great quote’ (source)
Informed consent (IC) is a the process by which a patient voluntarily agrees to a medical procedure, treatment, or participation in research participant is after being fully informed about the nature, purpose, risks, and potential benefits of a study or treatment. It ensures that individuals agree to participate voluntarily, with a full understanding of what their involvement entails. In the context of health data, informed consent relevant details. Obtaining patients’ informed consent is usually required when collecting their data for scientific purposes [De novo]. Furthermore, consent may be necessary for, for example, sharing and archiving [uu_consent] of the data and linkage with external registries.
To allow for the data to be machine-actionable, the IC information must be provided in a digital, standardised fashion, as without such information a computer cannot know whether it is allowed to use the data [FAIR].
There are many forms of IC. The image below illustrates some well-known variants and how they are related.
Depending on the type of study and the goals, specific rules for the allowed form of consent can exist. For example, an invasive study involving human subjects need to adhere to the rules set by the CCMO.
A general informed consent form may be available, but a local Institutional Ethical Review Board may demand changes after reviewing. It is crucial that essential data sharing aspects are explicitly handled in the informed consent form [De Novo]. The consent information should be made available as metadata.
IC is also vital for GDPR compliance, as processing personal data (especially sensitive health data) often requires explicit consent from the data subject. Furthermore, patient consent is necessary for, for example, archiving, sharing [uu_consent] and linkage with external registries. Furthermore, consent information is necessary for the data to be machine-actionable, as without such data a computer cannot know whether it is allowed to use the data [FAIR].
A general informed consent form is availableon the website of the CCMO, but a local Institutional Ethical Review Board may demand changes after reviewing and assesses whether the IC aligns with ethical standards, legal requirements and takes considerations into account such as age. This is important because:
It ensures that the consent form is written in a way that participants in that particular region can understand.
The local committee will assess whether the consent form adequately explains the data processing activities, the purpose of data collection, and participants' rights (e.g., the right to withdraw consent).
The committee ensures that the study adheres to local regulations regarding the use of personal and sensitive health data.
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[uu_consent] https://www.uu.nl/en/research/research-data-management/guides/informed-consent-for-data-sharing
Obtaining patients’ informed consent for collecting their data for scientific purposes is usually required [De novo]. Furthermore, patient consent may be necessary for archiving and sharing [uu_consent] and linkage with e.g. external registries. Furthermore, consent information is necessary for the data to be machine-actionable, as without such data a computer cannot know whether it is allowed to use the data [FAIR].
A general informed consent form may be available, but a local Institutional Ethical Review Board may demand changes after reviewing. because:
It ensures that the consent form is written in a way that participants in that particular region can understand.
The local committee will assess whether the consent form adequately explains the data processing activities, the purpose of data collection, and participants' rights (e.g., the right to withdraw consent).
The committee ensures that the study adheres to local regulations regarding the use of personal and sensitive health data.
It is crucial that essential data sharing aspects are explicitly handled in the informed consent form [De Novo]. The consent information should be made available as metadata. .
[uu_consent] https://www.uu.nl/en/research/research-data-management/guides/informed-consent-for-data-sharing
[uu_consent] https://www.uu.nl/en/research/research-data-management/guides/informed-consent-for-data-sharing
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